Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT03466632
Status:
UNKNOWN
Last Update Posted:
2018-03-15
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-03-09', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adequate sedation', 'timeFrame': '6 months', 'description': 'the number of patients adequately sedated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Diseases']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy', 'detailedDescription': 'Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 25-45 years,\n* ASA class I or II,\n* who are scheduled for elective outpatient colonoscopy\n\nExclusion Criteria:\n\n* refused to give informed consent\n* if they had known hypersensitivity to the used drugs\n* patients with morbidly obese patients\n* patients with increased risk for airway obstruction as obstructive sleep apnea,\n* Liver diseases'}, 'identificationModule': {'nctId': 'NCT03466632', 'briefTitle': 'Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': 'dexmedetomidine colonoscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '• Propofol Group', 'description': 'propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '• Dexmedetomidine Group', 'description': 'dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure.', 'armGroupLabels': ['• Propofol Group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure', 'armGroupLabels': ['• Dexmedetomidine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35455', 'city': 'Zagazig', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sameh Abdelkhalek Ahmed, MD', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201095159522'}], 'facility': 'Sameh Abdelkhalek Ahmed', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, MD', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Sherief Abd-Elsalam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}, {'name': 'Sameh Abdelkhalek Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University Anasthesia Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}